A phase 2, open-label, randomized, multiple-dose study evaluating Inarigivir in treatment-naïve patients with chronic...

Area of Science:

• Hepatology and Viral Hepatitis Research
• Immunomodulatory Drug Development
• Antiviral Therapy for Hepatitis B Virus

Background:

• Novel agents are crucial for achieving HBsAg seroclearance (functional cure) in hepatitis B virus (HBV) infection.
• Inarigivir, a retinoic acid-inducible gene I agonist, exhibits both immunomodulatory and direct antiviral properties against HBV.

Purpose of the Study:

• To evaluate the safety and efficacy of Inarigivir in patients with HBV infection.
• To determine the optimal dosage of Inarigivir for HBV treatment.

Main Methods:

• A randomized, double-blind, placebo-controlled trial involving 80 treatment-naïve patients.
• Ascending doses of Inarigivir (25, 50, 100, 200 mg) or placebo were administered for 12 weeks.
• All patients subsequently received 12 weeks of tenofovir treatment.

Main Results:

• Inarigivir treatment led to dose-dependent reductions in HBV DNA, HBV RNA, and HBsAg levels compared to placebo.
• Mean reductions in ALT levels were observed in Inarigivir-treated groups.
• Treatment-emergent adverse events were comparable between Inarigivir and placebo groups.

Conclusions:

• A 12-week treatment with Inarigivir up to 200 mg showed reductions in HBV DNA, RNA, and antigen levels.
• A trend towards greater HBsAg reduction was noted in patients pre-treated with Inarigivir before switching to tenofovir.
• Inarigivir appears to be a safe and potentially effective agent for HBV treatment, warranting further investigation for functional cure.